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The Coligne GII Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The GII Spinal Fixation System is intended for use in the non-cervical posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft and/or allograft, the GII Spinal Fixation System is intended for use or more of the following; (1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal stenosis, (6) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Coligne GII Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma.

This system is intended to be used with autograft. Pediatic pedicle screw fixation is limited to a posterior approach.

The GII Spinal Fixation System is a top loading polyaxial pedicle screw, which, when used with rods and crosslinks, results in a multiple component, posterior system. All the components are available in a variety of sizes to match the patient's anatomy more closely.

This document outlines the FDA's 510(k) premarket notification clearance for the Coligne GII Spinal Fixation System. The focus of the 510(k) submission is to add flexStaas pedicle screws to the existing system.

Based on the provided text, the device in question is a Spinal Fixation System, and the "study" referred to is a non-clinical test summary to demonstrate that the new component (flexStaas pedicle screws) meets performance criteria compared to predicate devices. There were no clinical studies performed.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the flexStaas pedicle screws of the GII Spinal Fixation System met or exceeded acceptance criteria for two specific non-clinical tests. However, the specific quantitative acceptance criteria values are not explicitly stated in this document. Only the types of tests and the outcome ("met or exceeded") are provided.

Note: The document only provides a qualitative summary of the non-clinical test results. The actual quantitative acceptance criteria and the measured performance values would be detailed in the full test reports, which are not included in this FDA clearance letter.

Study Information (Non-Clinical)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for the non-clinical tests. The number of samples for dynamic flexion-extension and torsional strength tests is typically specified in the test protocols, but not in this summary.
   • Data Provenance: The tests were performed "in support of this Special 510(k)". It is implied that these tests were conducted by the manufacturer, Coligne AG, or a contracted testing facility. The country of origin of the data is not specified beyond the company being located in Zurich, Switzerland. The tests are prospective in the sense that they were performed to support the submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This was a non-clinical, mechanical testing study, not a study involving expert review of medical images or patient outcomes. The "ground truth" for mechanical tests is defined by established engineering standards (ASTM F1798) and material properties.

3. Adjudication method for the test set:

   • Not Applicable. This was a non-clinical, mechanical testing study. Adjudication methods like 2+1 or 3+1 are used for human reader studies or when establishing ground truth from multiple expert opinions.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted. This device is a mechanical implant, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a mechanical device, not an algorithm. Standalone performance refers to the accuracy or performance of an AI algorithm independent of human intervention.

6. The type of ground truth used:

   • For the non-clinical tests, the "ground truth" is based on established engineering standards (specifically ASTM F1798 for dynamic testing) and material property specifications (e.g., strength requirements for medical implants). It's not a medical "ground truth" like pathology or clinical outcomes.

7. The sample size for the training set:

   • Not Applicable. The document describes a mechanical device requiring non-clinical testing, not a machine learning model that would have a training set.

8. How the ground truth for the training set was established:

   • Not Applicable. As no training set was involved (this is a mechanical device), no ground truth for a training set needed to be established.

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The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:

(1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S1) joint with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(6) Spinal tumor, and/or

(7) Failed previous fusion (pseudoarthrosis).

The GII spinal fixation system when used as a hook and sacral/iliac screw fixation system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:

(1) Degenerative spondylolisthesis with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(7) Spinal tumor, and/or

(8) Failed previous fusion (pseudoarthrosis).

The new GII-Ti-Poly-Axial Screw is intended to be used with the existing components, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. The previously cleared indications for use of the GII Spinal Fixation System are unchanged.

Acceptance Criteria and Device Performance Study for GII-Ti-Poly-Axial Screw

This document describes the acceptance criteria and the study that proves the GII-Ti-Poly-Axial Screw meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states, "Samples were tested according to accepted engineering and scientific principals." However, it does not provide specific details on:

• The exact sample size used for the mechanical testing of the GII-Ti-Poly-Axial Screw.
• The data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a mechanical device test, it is highly likely that the testing was performed in a laboratory setting, likely in Switzerland or at a contract testing facility, and therefore prospective in nature.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

For a mechanical device like a spinal screw, "ground truth" in the context of clinical outcomes or expert consensus on images is not directly applicable. The "ground truth" here is established by engineering standards and validated testing methodologies to confirm mechanical equivalence. The document does not specify the number or qualifications of experts involved in defining these engineering standards or conducting the tests. It broadly states, "Testing is complete. Samples were tested according to accepted engineering and scientific principals."

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., image reading). Since this study involves mechanical testing of a device's performance against established engineering standards, an adjudication method is not applicable in the traditional sense. The equivalence is demonstrated through objective mechanical measurements and data analysis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is designed to assess the impact of a device or AI on human reader performance, typically in diagnostic imaging. This type of study was not performed for the GII-Ti-Poly-Axial Screw, as it is a mechanical implant and not an imaging or diagnostic AI device. Therefore, there is no effect size for human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study (algorithm only) is relevant for AI/software devices. Since the GII-Ti-Poly-Axial Screw is a physical medical implant, a standalone performance study is not applicable in this context. Its "performance" is demonstrated through physical and mechanical testing, not algorithmic output.

7. Type of Ground Truth Used

The ground truth used for this device is based on established engineering standards and validated mechanical testing protocols. The performance of the new GII-Ti-Poly-Axial Screw is compared directly against the performance characteristics of previously cleared predicate devices (K980852, K032604, K051089) within the GII Spinal Fixation System. This includes characteristics like design, material composition, and mechanical properties determined through testing.

8. Sample Size for the Training Set

For a mechanical device undergoing performance testing for substantial equivalence, a "training set" as understood in machine learning is not applicable. The device is not learning from data; its physical properties are being tested. If "training set" were to broadly refer to the predicate devices and their established performance data that serve as a benchmark, the document references several existing screw components from the GII Spinal Fixation System (K980852, K032604, K051089). The specific number of individual units of these predicate devices used to establish their performance is not provided in this summary.

9. How Ground Truth for the Training Set Was Established

Again, a "training set" in the AI sense does not apply here. However, if we interpret "ground truth for the training set" as the established performance baseline of the predicate devices, this baseline was established through:

• Prior mechanical testing of the predicate devices according to accepted engineering and scientific principles.
• Regulatory clearance (e.g., via previous 510(k) submissions K980852, K032604, and K051089) which confirmed their safety and effectiveness based on their design, materials, and performance data at the time of their clearance.
• Adherence to recognized standards relevant to spinal implants (though specific standards are not cited in this summary).

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The GII Spinal Fixation System When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII@ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the GII@ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The GII system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).

The new plates are offered in a series of sizes designated by the number of slots or holes within the plates. The I ho w plates are single slot. The new plates are provided precurved to more closely match the natural lordotic curve of the lumbar spine. Two different curves are offered in each size.

The devices are produced of a polyner matrix of Polyetherketonekctone (PEKEKK) Resins and long fiber carbon filaments.

The new plates are intended to be used with the existing pedicle screws, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. Because the new material is not a metallic material, precautions against mixing dissimilar metals or of a galvanic/corrosive interaction with the existing implants is eliminated.

The previously cleared indications for use are unchanged.

This document is a 510(k) premarket notification for the GII OstaPek® Plate from COLIGNE AG. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a detailed study report with acceptance criteria and reported device performance in the way typically expected for an AI/ML device.

This submission is for a medical implant (spinal fixation system), not a software/AI device that would involve performance metrics like sensitivity, specificity, or accuracy based on human interpretation or algorithm output. The "acceptance criteria" here refer to compliance with material, mechanical, and biocompatibility standards, which are physical tests rather than clinical study results comparing algorithm performance.

Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory document. I will answer the applicable points based on the information provided.

1. Table of acceptance criteria and the reported device performance

For this medical implant, acceptance criteria and performance are related to physical and biological properties.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for mechanical and biocompatibility testing. These tests typically involve a specific number of samples per test type according to the relevant standards (e.g., n=5 or n=10 per test for fatigue).
• Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable in the context of device performance testing. The company is based in Zurich, Switzerland, and the submission is to the US FDA. The testing would have been conducted in a laboratory setting, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts & Qualifications: Not applicable. Ground truth for mechanical and biocompatibility testing is established through standardized laboratory methods and measurements, not by human expert consensus or clinical interpretation.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Standardized lab tests have defined pass/fail criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No. This is not a diagnostic device or an AI/ML software; it is a physical implant. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: For this device, ground truth is established through:
  • Validated Physical Measurements: Mechanical properties (e.g., strength, fatigue life) are measured using calibrated testing equipment against established engineering standards (e.g., ASTM standards).
  • Biocompatibility Testing: Assessed through in-vitro and in-vivo biological response tests following ISO standards.
  • Material Characterization: Chemical composition and properties verified against material specifications.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is not an AI/ML model that requires a training set. The "development" would involve engineering design and prototyping, not data training.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable. See point 8.

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When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the GII Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The GII Spinal system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

The GII Spinal Fixation System implants are intended to be used as temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures, attaching longitudinal member to the spine by means of spinal anchors. The GII Spinal System is both a rod-based systems and a plate-based system designed on the same pedicular screw foundation. The longitudinal members consist of spinal rods or plates. The spinal anchors consist of pedicular screws. Transverse connectors are also included in the system to provide rigidity to the construct. Optional construct spacers are available to allow better seating of the plates or connectors onto the pedicular screws as well as poliaxiality.

The provided text describes a medical device, the GII Spinal Fixation System, and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in the context of typical AI/software performance evaluation.

Instead, the document focuses on regulatory equivalence to predicate devices, device description, and indications for use. The "Performance Characteristics" section explicitly states: "Static and Fatigue tests results were supplied to substantiate significant equivalence with previously cleared components." This indicates an engineering-based performance assessment for mechanical equivalence, not a clinical or AI-driven performance study comparing outputs to a ground truth or human readers.

Therefore, I cannot provide the requested information from the provided text for most of the points.

Here's what I can extract and what is missing:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of clinical or AI performance metrics. The underlying acceptance criteria for this type of device (spinal fixation system) would typically relate to mechanical strength, fatigue life, biocompatibility, and sterilization, demonstrating equivalence to predicate devices.
• Reported Device Performance: "Static and Fatigue tests results were supplied to substantiate significant equivalence with previously cleared components." No specific numerical performance values (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) are provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not present. The document describes mechanical tests, not a clinical performance study with a 'test set' of data in the AI sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not present. Ground truth establishment by experts is relevant for clinical or diagnostic AI systems, not for a spinal fixation system's mechanical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not present.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable / Not present. This device is a physical implant, not an AI diagnostic tool that would assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not present.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable / Not present. For mechanical testing, the "ground truth" would be established engineering standards (e.g., ASTM or ISO standards for spinal implants) and direct measurement of mechanical properties, rather than clinical ground truth types.

8. The sample size for the training set

• Not applicable / Not present. This device is not an AI algorithm.

9. How the ground truth for the training set was established

• Not applicable / Not present.

In summary, the provided document is a 510(k) summary for a physical medical device (spinal fixation system) and discusses its regulatory clearance based on substantial equivalence to predicate devices, primarily substantiated by mechanical performance tests (Static and Fatigue tests). It does not contain the characteristics of a study for evaluating AI or software performance as requested in your prompt.

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The GII Spinal Fixation System using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of pedicle screw fixation may be from L3 to the sacrum.

The GII Spinal Fixation System is available in stainless steel and titanium alloy and includes plates, screws and optional spacers. Plates are offered in a variety of lengths (41.1 to 141.2mm) and have longitudinal openings to accommodate the mechanical thread portion of the screw. Screws are have both cancellous and mechanical threads, and are available with mechanical thread lengths of 27 or 12mm, cancellous thread lengths ranging from 37 to 52mm in 5mm increments and cancellous thread outer diameters ranging from 5.5 to 8.5mm. Optional spacers are available in 3 or 5mm heights or in a 1.5 to 5mm angled height.

The request is asking for details about the acceptance criteria and the study that proves a device, the GII Spinal Fixation System, meets those criteria, based on the provided 510(k) summary and FDA letter.

However, after reviewing the provided documents, it is clear that this submission pertains to a spinal fixation system (a mechanical device), not an AI/ML-driven medical device.

Therefore, many of the requested fields, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "sample size for the test set," "data provenance," "number of experts for ground truth," "adjudication method," "type of ground truth," "sample size for training set," and "how ground truth for training set was established," are not applicable to this type of device and are not addressed in the provided documents.

The primary evidence presented for this device's performance, as stated under "Performance Characteristics" in the 510(k) Summary, revolves around mechanical testing.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Device Performance for GII Spinal Fixation System

Regarding the other requested information:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable / Not provided. For mechanical testing, samples refer to the device components tested, not patient data. The documents do not specify the number of components tested for static and fatigue performance, nor their provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. Ground truth in the context of AI/ML or clinical studies is not relevant here. For mechanical testing, the "ground truth" is measured physical properties, typically against engineering standards or predicate device performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This refers to clinical or expert review processes, which are not detailed for mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a mechanical device, not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • No. This is a mechanical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Mechanical properties / Engineering standards. For a mechanical device, the ground truth for performance relates to physical measurements (e.g., load-bearing capacity, fatigue life) against established engineering standards or comparative data from predicate devices. The exact standards are not listed in these documents.

8. The sample size for the training set:

   • Not applicable. There is no "training set" for this type of device approval.

9. How the ground truth for the training set was established:

   • Not applicable. There is no "training set."

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